NCT06014047

Brief Summary

This study evaluates the short-term and long-term patency of the radial artery and the No-touch vein in patients undergoing isolated on-pump/off-pump coronary artery bypass graft (CABG) surgery. A total of at least 774 patients undergoing isolated on-pump/off-pump CABG will be consecutively recruited from Fuwai Hospital and randomly assigned to receive radial artery or No-touch saphenous vein as their second graft. All participants will be invited for clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis at 3 months and 12 months post-operatively.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
774

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
54mo left

Started Nov 2023

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Nov 2023Oct 2030

First Submitted

Initial submission to the registry

August 23, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2030

Last Updated

October 17, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

August 23, 2023

Last Update Submit

October 15, 2023

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasecoronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

  • Prevalence of graft patency

    All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.

    12 months after procedure

Secondary Outcomes (7)

  • Prevalence of graft patency

    3 months, 3 years and 5 years after procedure

  • Overall major adverse cardiac or cerebrovascular events (MACCE) rate

    3 months, 12 months, 3 years and 5 years after procedure

  • Cardiac death

    3 months, 12 months, 3 years and 5 years after procedure

  • Documented non-lethal myocardial infarction

    3 months, 12 months, 3 years and 5 years after procedure

  • Stroke

    3 months, 12 months, 3 years and 5 years after procedure

  • +2 more secondary outcomes

Study Arms (2)

No-Touch vein

EXPERIMENTAL

No-touch vein group has two No-touch saphenous vein grafts, anastomose to the right coronary or left coronary system. All patients also acquired LITA-LAD anastomosis to complete the revascularization.

Procedure: No-touch vein graft

Radial artery

ACTIVE COMPARATOR

Radial artery group has one radial artery graft and one conventional saphenous vein graft, anastomose to the right coronary or left coronary system basing on surgeons' decision. All patients also acquired LITA-LAD anastomosis to complete the revascularization.

Procedure: Radial artery graft

Interventions

No-touch vein graftPROCEDURE

Two No-touch saphenous vein grafts anastomose to the right coronary and left coronary system. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.

No-Touch vein
Radial artery graftPROCEDURE

One radial artery graft and one conventional saphenous vein graft anastomose to the right coronary or left coronary system basing on surgeons' decision. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.

Radial artery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18 years old
  • First time undergo isolated CABG surgery
  • Severe three-vessel disease (Left anterior decending artery, Left circumflex artery, Right coronoary artery lesion with more than 75% stenosis)

You may not qualify if:

  • Urgent or Redo CABG surgery
  • Concomitant cardiac or vascular procedures (i.e. valve repair or replacement, Morrow procedure)
  • A positive Allen test, radial artery plaque on ultrasound or a history of vasculitis or Raynaud's syndrome
  • Varicose great saphenous vein or venous tortuosity and judged as can not be used in operation by surgeons
  • Known allergy to radiographic contrast media
  • Planed endarterectomy of coronary artery before surgery
  • Malignant tumor or other severe systemic diseases
  • Combined with other irreversible organ failures
  • Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
  • Participant of other ongoing clinical trials in 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (3)

  • Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.

    PMID: 34510911RESULT

  • Nappi F, Bellomo F, Nappi P, Chello C, Iervolino A, Chello M, Acar C. The Use of Radial Artery for CABG: An Update. Biomed Res Int. 2021 Apr 7;2021:5528006. doi: 10.1155/2021/5528006. eCollection 2021.

    PMID: 33928147RESULT

  • Zhang F, Tian M, Wang X, Zhang H, Zhou X, Liu R, Liu R, Jin Z, Zhang C, Wang X. Rationale and design of a single-center randomized trial to compare the graft patency between the radial artery and the no-touch saphenous vein in coronary artery bypass grafting surgery (GRAFT-CAB Study). Am Heart J. 2024 Aug;274:46-53. doi: 10.1016/j.ahj.2024.05.001. Epub 2024 May 6.

    PMID: 38710379DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Shengshou Hu, M.D.

CONTACT

+86-10-88398359shengshouhu@yahoo.com

Meice Tian, M.D.

CONTACT

+8613718863077tianmeice@fuwaihospital.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 28, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2030

Last Updated

October 17, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)